BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161604 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02233
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Report Date
    August 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION FOR THE PROCEDURE WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS REPORTED TO BE: 3.5 MM VESSEL DIAMETER, NOT CALCIFIED, 12 MM LENGTH, AND TYPE B2. THERE WERE NO REPORTED PROBLEMS NOTED ON INSPECTION OF THE DEVICE OR IN PREPPING THE DEVICE. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AFTER IMPLANTATION OF A CYPHER SELECT PLUS 3.5 X 18 MM STENT, THE PHYSICIAN EXPERIENCED WITHDRAWAL DIFFICULTY OF THE STENT DELIVERY SYSTEM (SDS) BALLOON. THE REPORT INDICATED THAT THE BALLOON SEEMED TO STICK/ADHERE TO THE STENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD A GOOD OUTCOME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13373628

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 6 FR. JL4 GUIDING CATHETER